Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain (HEART Pathway)
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|ClinicalTrials.gov Identifier: NCT01665521|
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Chest Pain||Other: HEART Pathway||Not Applicable|
Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. The total cost of chest pain evaluations has been estimated at $5-10 billion annually, yet only 10% of these patients are ultimately diagnosed with an acute coronary syndrome. American College of Cardiology/ American Heart Association (ACC/AHA) guidelines recommend that patients at low-risk for acute coronary syndrome should receive serial cardiac markers followed by objective cardiac testing (stress testing or cardiac imaging). However, many have questioned the value of objective cardiac testing in all low-risk patients.Cardiac testing for all patients at low-risk for acute coronary syndrome (ACS) is not sustainable from a healthcare quality or economic perspective. In addition to increasing costs, objective cardiac testing is associated with a substantial number of false positive and non-diagnostic tests, which lead to additional unnecessary and often invasive procedures.
Implementation of accurate risk stratification care pathways designed to eliminate unnecessary cardiac testing could improve the efficiency and quality of care by decreasing false positive/non-diagnostic testing, radiation, and costs. The HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, is a recently developed care pathway designed to identify chest pain patients for early discharge without objective testing.
Primary Hypothesis: The HEART Pathway, when compared to usual care, will reduce 30 day objective cardiac testing, hospital length of stay, and cost, while maintaining patient safety.
Methods: Participants (n=282) at risk for ACS will be recruited into a clinical trial from Wake Forest Baptist Medical Center (WFBMC) ED. Patients will be equally randomized to HEART Pathway or Usual Care. HEART Pathway participant's treating physician will follow HEART Pathway guidelines for identifying patients to be admitted to the hospital or observation unit for cardiac testing or to be discharged home without testing. Usual Care participant's treating physicians will decide whether the patients should be discharged home or admitted to the hospital or observation unit based on ACC/AHA guidelines without using the HEART pathway.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain|
|Actual Study Start Date :||September 2012|
|Actual Primary Completion Date :||February 20, 2016|
|Actual Study Completion Date :||January 15, 2018|
Experimental: HEART Pathway
The HEART Pathway will be used for real time clinical decision making. Physicians will receive care recommendations according to the HEART Pathway, based on HEART score and serial cardiac biomarkers. This will help physicians identify low-risk patients for early discharge with no objective cardiac testing.
Other: HEART Pathway
During ED evaluation, patients are randomized to HEART Pathway or usual care arms.
No Intervention: Usual Care
Conventional Care cardiac testing. Patients will undergo cardiac testing as determined by their treating physicians.
- Objective cardiac testing (stress testing or cardiac imaging) within 30 days [ Time Frame: 30 Days ]Rate of objective cardiac testing within 30 days
- Cost, length of stay, recurrent ED visits and non-index hospitalization for chest pain. [ Time Frame: 30 Days ]
- Objective cardiac testing (stress testing or cardiac imaging), cost, length of stay, and recurrent ED visits and non-index hospitalization for chest pain. [ Time Frame: 1 Year ]
- Index objective cardiac testing rate [ Time Frame: Duration of Index Hospitalization, average of 1 to 2 days ]proportion of patients receiving any stress testing modality, coronary computed tomography angiography, or invasive catheter angiography at the index visit
- Index Hospital Admission Rate [ Time Frame: Duration of Index Hospitalization, average of 1 to 2 days ]Proportion of patients hospitalized for admission or observation during the index visit
- Early discharge rate [ Time Frame: Duration of Index Hospitalization, average of 1 to 2 days ]Proportion of patients that are discharged from the Emergency Department without meeting the composite endpoint of index hospital admission or index objective cardiac testing
- Composite of 30 day hospital admission and objective cardiac testing [ Time Frame: 30 Days ]
- Major adverse cardiac events (MACE) [ Time Frame: 30 Days and 1 Year ]
- Missed MACE [ Time Frame: 30 Days and 1 Year ]MACE occurring in patients discharged without objective cardiac testing.
- Provider adherence to the HEART Pathway [ Time Frame: Duration of Index Hospitalization, average of 1 to 2 days ]
- Inter-rater reliability of the HEART Pathway [ Time Frame: Duration of the Index ED visit, less than 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665521
|United States, North Carolina|
|Wake Forest Wake Forest University Baptist Medical Center - Emergency Department|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Simon A Mahler, MD||Wake Forest Baptist Medical Center|